Table 1.

Potential cytokine inhibition/agonists applicable to the prevention of aGVHD

TargetReagentDisease settingClinical trial status/outcomeClinical Trial IDReference
TNF TNFR-Fc GVHD prophylaxis Phase 2, II-IV aGVHD 46%, but steroid-refractory GI GVHD is 23% NCT00639717 26,27  
TNFR-Fc GVHD treatment (as initial therapy) Phase 2, TNFR-Fc was inferior to MMF with lower CR NCT00224874 25  
IL-1β Human rIL-1Ra GVHD prophylaxis Phase 3, no reduction in the incidence of aGVHD  31  
IL-33R Anti-ST2 Ab COPD Phase 2, active, not recruiting NCT03615040  
IL-6R Anti-IL-6 receptor Ab GVHD prophylaxis Phase 1/2, low rates grade II-IV aGVHD NCT02206035* 24,124 * 
IL-12/23 p40 Anti-IL-12/23 p40 Ab GVHD prophylaxis Phase 1/2, improved OS and GRFS NCT01713400 134  
IL-23 p19 Anti-IL-23p19 Ab Psoriasis Phase 3, improved efficacy compared with anti-TNFα Ab NCT02207231 135  
NCT02207244 
Ulcerative colitis Phase 2/3, active, recruiting NCT04033445  
Phase 2, active, recruiting NCT03662542 
Crohn disease Phase 2/3, active, recruiting NCT03466411  
IL-17A Anti-IL-17A Ab Active rheumatoid arthritis Phase 3, secukinumab was inferior to abatacept with lower response rates NCT01350804 154  
Ankylosing spondylitis (AS) Phase 3, improved AS symptoms and low mean progression in spinal radiographic change NCT01358175 153  
Plaque psoriasis Phase 3, effective in 2 randomized trials NCT01365455 152  
NCT01358578 
IL-2 Anti-CD25 Ab GVHD prophylaxis Phase 3, no reduction in aGVHD  144  
IL-22 Human IL-22 IgG2-FC GVHD treatment (II to IV lower GI tract GVHD) Phase 2a, active, not recruiting NCT02406651  
IL-2 Human rIL-2 GVHD prophylaxis Phase 2, eliminated grade II-IV aGVHD (0% vs 13%) NCT00539695 142  
Phase 2, no reduction in the aGVHD NCT01927120 143  
TargetReagentDisease settingClinical trial status/outcomeClinical Trial IDReference
TNF TNFR-Fc GVHD prophylaxis Phase 2, II-IV aGVHD 46%, but steroid-refractory GI GVHD is 23% NCT00639717 26,27  
TNFR-Fc GVHD treatment (as initial therapy) Phase 2, TNFR-Fc was inferior to MMF with lower CR NCT00224874 25  
IL-1β Human rIL-1Ra GVHD prophylaxis Phase 3, no reduction in the incidence of aGVHD  31  
IL-33R Anti-ST2 Ab COPD Phase 2, active, not recruiting NCT03615040  
IL-6R Anti-IL-6 receptor Ab GVHD prophylaxis Phase 1/2, low rates grade II-IV aGVHD NCT02206035* 24,124 * 
IL-12/23 p40 Anti-IL-12/23 p40 Ab GVHD prophylaxis Phase 1/2, improved OS and GRFS NCT01713400 134  
IL-23 p19 Anti-IL-23p19 Ab Psoriasis Phase 3, improved efficacy compared with anti-TNFα Ab NCT02207231 135  
NCT02207244 
Ulcerative colitis Phase 2/3, active, recruiting NCT04033445  
Phase 2, active, recruiting NCT03662542 
Crohn disease Phase 2/3, active, recruiting NCT03466411  
IL-17A Anti-IL-17A Ab Active rheumatoid arthritis Phase 3, secukinumab was inferior to abatacept with lower response rates NCT01350804 154  
Ankylosing spondylitis (AS) Phase 3, improved AS symptoms and low mean progression in spinal radiographic change NCT01358175 153  
Plaque psoriasis Phase 3, effective in 2 randomized trials NCT01365455 152  
NCT01358578 
IL-2 Anti-CD25 Ab GVHD prophylaxis Phase 3, no reduction in aGVHD  144  
IL-22 Human IL-22 IgG2-FC GVHD treatment (II to IV lower GI tract GVHD) Phase 2a, active, not recruiting NCT02406651  
IL-2 Human rIL-2 GVHD prophylaxis Phase 2, eliminated grade II-IV aGVHD (0% vs 13%) NCT00539695 142  
Phase 2, no reduction in the aGVHD NCT01927120 143  

COPD, chronic obstructive pulmonary disease; CR, complete response; GRFS, GVHD/relapse-free survival; OS, overall survival.

*

Drobyski et al124 is related to NCT02206035.

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